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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02340221




Registration number
NCT02340221
Ethics application status
Date submitted
13/01/2015
Date registered
16/01/2015
Date last updated
12/07/2022

Titles & IDs
Public title
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Scientific title
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Secondary ID [1] 0 0
2014-003185-25
Secondary ID [2] 0 0
GO29058
Universal Trial Number (UTN)
Trial acronym
SANDPIPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Taselisib
Treatment: Drugs - Placebo
Treatment: Drugs - Fulvestrant

Experimental: Taselisib + Fulvestrant - Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.

Placebo Comparator: Placebo + Fulvestrant - Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.


Treatment: Drugs: Taselisib
Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.

Treatment: Drugs: Placebo
Placebo matching to taselisib was administered as per the schedule specified in the respective arm.

Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Primary outcome [2] 0 0
PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis
Timepoint [2] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis
Timepoint [2] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary outcome [3] 0 0
Overall Survival (OS) at Primary Analysis
Timepoint [3] 0 0
From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [4] 0 0
OS at Final Analysis
Timepoint [4] 0 0
From randomization up to death from any cause (up to approximately 6.2 years)
Secondary outcome [5] 0 0
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis
Timepoint [5] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [6] 0 0
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis
Timepoint [6] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary outcome [7] 0 0
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis
Timepoint [7] 0 0
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [8] 0 0
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis
Timepoint [8] 0 0
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary outcome [9] 0 0
PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis
Timepoint [9] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [10] 0 0
PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis
Timepoint [10] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events at Primary Analysis
Timepoint [11] 0 0
From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.
Secondary outcome [12] 0 0
Percentage of Participants With Adverse Events at Final Analysis
Timepoint [12] 0 0
From randomization up to approximately 6.2 years
Secondary outcome [13] 0 0
Maximum Observed Plasma Concentration (Cmax) of Taselisib
Timepoint [13] 0 0
1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)
Secondary outcome [14] 0 0
Minimum Observed Plasma Concentration (Cmin) of Taselisib
Timepoint [14] 0 0
1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)
Secondary outcome [15] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
Timepoint [15] 0 0
Baseline, C2D1 up to C7D1 (each cycle=28 days)
Secondary outcome [16] 0 0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score
Timepoint [16] 0 0
Baseline, C2D1 up to C7D1 (each cycle=28 days)

Eligibility
Key inclusion criteria
- Postmenopausal women with histologically or cytologically confirmed locally advanced
or metastatic estrogen receptor (ER) positive breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended
and treatment with cytotoxic chemotherapy is not indicated at time of entry into the
study

- Radiologic/objective evidence of recurrence or progression to the most recent systemic
therapy for breast cancer

- Radiologic/objective evidence of breast cancer recurrence or progression while on or
within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or
progression while on or within 1 month of the end of prior AI treatment for locally
advanced or metastatic breast cancer

- Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version
1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone
lesion via RECIST v1.1

- Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block
(preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from
the most recently collected, available tumor tissue for oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing

- A valid cobas PIK3CA mutation result by central testing is required

- Adequate hematologic and end-organ function within 28 days prior to treatment
initiation
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory
testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization
positive)

- Prior treatment with fulvestrant

- Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian
target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT)
inhibitor

- Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1

- Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1

- All acute treatment-related toxicity must have resolved to Grade less than or equal to
(</=) 1 or be deemed stable by the Investigator

- Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic
breast cancer

- Concurrent hormone replacement therapy

- Known untreated or active central nervous system (CNS) metastases

- Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications

- History of inflammatory bowel disease or active bowel inflammation

- Clinically significant cardiac or pulmonary dysfunction

- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with human immunodeficiency virus (HIV),
hepatitis B or C virus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2021
Sample size
Target
Accrual to date
Final
631
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital; Cancer Therapy Centre - Liverpool
Recruitment hospital [2] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital; Oncology - Waratah
Recruitment hospital [4] 0 0
Mater Hospital; Oncology - Brisbane
Recruitment hospital [5] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [6] 0 0
Sunshine Hospital; Oncology Research - St Albans
Recruitment hospital [7] 0 0
St John of God Murdoch Hospital; Oncology West - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
- St Albans
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Bosnia and Herzegovina
State/province [15] 0 0
Banja Luka
Country [16] 0 0
Bosnia and Herzegovina
State/province [16] 0 0
Sarajevo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Varna
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
China
State/province [24] 0 0
Changchun
Country [25] 0 0
China
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Nanjing City
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China
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Shanghai City
Country [27] 0 0
China
State/province [27] 0 0
Zhejiang
Country [28] 0 0
Colombia
State/province [28] 0 0
Bogota
Country [29] 0 0
Colombia
State/province [29] 0 0
Monteria
Country [30] 0 0
Czechia
State/province [30] 0 0
Hradec Kralove
Country [31] 0 0
Czechia
State/province [31] 0 0
Olomouc
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 2
Country [33] 0 0
Finland
State/province [33] 0 0
Kuopio
Country [34] 0 0
Finland
State/province [34] 0 0
Turku
Country [35] 0 0
France
State/province [35] 0 0
Clermont-Ferrand
Country [36] 0 0
France
State/province [36] 0 0
Dijon
Country [37] 0 0
France
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Guilherand Granges
Country [38] 0 0
France
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La Roche Sur Yon
Country [39] 0 0
France
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Limoges
Country [40] 0 0
France
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Montpellier
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France
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Paris
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France
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Pierre Benite
Country [43] 0 0
France
State/province [43] 0 0
Strasbourg
Country [44] 0 0
France
State/province [44] 0 0
Vandoeuvre-les-nancy
Country [45] 0 0
Germany
State/province [45] 0 0
Bad Nauheim
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Essen
Country [48] 0 0
Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
München
Country [50] 0 0
Germany
State/province [50] 0 0
Trier
Country [51] 0 0
Greece
State/province [51] 0 0
Athens
Country [52] 0 0
Greece
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Heraklion
Country [53] 0 0
Greece
State/province [53] 0 0
Patras
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Italy
State/province [55] 0 0
Campania
Country [56] 0 0
Italy
State/province [56] 0 0
Emilia-Romagna
Country [57] 0 0
Italy
State/province [57] 0 0
Friuli-Venezia Giulia
Country [58] 0 0
Italy
State/province [58] 0 0
Liguria
Country [59] 0 0
Italy
State/province [59] 0 0
Lombardia
Country [60] 0 0
Italy
State/province [60] 0 0
Sicilia
Country [61] 0 0
Italy
State/province [61] 0 0
Toscana
Country [62] 0 0
Italy
State/province [62] 0 0
Veneto
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Busan
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Cheongju-si
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Goyang-si
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Ulsan
Country [68] 0 0
Mexico
State/province [68] 0 0
D.f.
Country [69] 0 0
Mexico
State/province [69] 0 0
Distrito Federal
Country [70] 0 0
Mexico
State/province [70] 0 0
Mexico City
Country [71] 0 0
Mexico
State/province [71] 0 0
Monterrey
Country [72] 0 0
Mexico
State/province [72] 0 0
Oaxaca
Country [73] 0 0
Netherlands
State/province [73] 0 0
Alkmaar
Country [74] 0 0
Netherlands
State/province [74] 0 0
Arnhem
Country [75] 0 0
Peru
State/province [75] 0 0
Lima
Country [76] 0 0
Peru
State/province [76] 0 0
Trujillo
Country [77] 0 0
Poland
State/province [77] 0 0
Bialystok
Country [78] 0 0
Poland
State/province [78] 0 0
Bydgoszcz
Country [79] 0 0
Poland
State/province [79] 0 0
Gdansk
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Poland
State/province [80] 0 0
Konin
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Poland
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Kraków
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Szczecin
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Poland
State/province [85] 0 0
Warszawa
Country [86] 0 0
Poland
State/province [86] 0 0
Wroclaw
Country [87] 0 0
Portugal
State/province [87] 0 0
Almada
Country [88] 0 0
Portugal
State/province [88] 0 0
Lisboa
Country [89] 0 0
Portugal
State/province [89] 0 0
Porto
Country [90] 0 0
Romania
State/province [90] 0 0
Bucuresti
Country [91] 0 0
Romania
State/province [91] 0 0
Cluj Napoca
Country [92] 0 0
Romania
State/province [92] 0 0
Craiova
Country [93] 0 0
Romania
State/province [93] 0 0
Iasi
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Moskovskaja Oblast
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Arkhangelsk
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Ivanovo
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Kazan
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Orenburg
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Saint-Petersburg
Country [100] 0 0
Serbia
State/province [100] 0 0
Belgrade
Country [101] 0 0
Spain
State/province [101] 0 0
LA Coruña
Country [102] 0 0
Spain
State/province [102] 0 0
Madrid
Country [103] 0 0
Spain
State/province [103] 0 0
Tenerife
Country [104] 0 0
Spain
State/province [104] 0 0
Vizcaya
Country [105] 0 0
Spain
State/province [105] 0 0
Barcelona
Country [106] 0 0
Spain
State/province [106] 0 0
Valencia
Country [107] 0 0
Spain
State/province [107] 0 0
Zaragoza
Country [108] 0 0
Sweden
State/province [108] 0 0
Linköping
Country [109] 0 0
Sweden
State/province [109] 0 0
Stockholm
Country [110] 0 0
Sweden
State/province [110] 0 0
Uppsala
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taipei City
Country [112] 0 0
Taiwan
State/province [112] 0 0
Taipei
Country [113] 0 0
Thailand
State/province [113] 0 0
Bangkok
Country [114] 0 0
Thailand
State/province [114] 0 0
Chiang Mai
Country [115] 0 0
Turkey
State/province [115] 0 0
Adana
Country [116] 0 0
Turkey
State/province [116] 0 0
Edirne
Country [117] 0 0
Turkey
State/province [117] 0 0
Istanbul
Country [118] 0 0
Turkey
State/province [118] 0 0
Izmir
Country [119] 0 0
Turkey
State/province [119] 0 0
Sihhiye/Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This international, multicenter, randomized, double-blinded, placebo-controlled study is
designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo +
fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal
growth factor receptor-2 (HER2)-negative, oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally
advanced or metastatic breast cancer after recurrence or progression during or after an
aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm
versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant
tumors via central testing. The anticipated duration of the study is approximately 3.5 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02340221
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02340221